950# Principal/Lead Statistical Programmer Consultant (Cardiovascular)-remote

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Principal/Lead Programmer Consultant to join one of our clients in Cardiovascular TA Team. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Job Overview

The Principal/Lead Statistical Programmer will serve as a key technical expert in the design, implementation, and delivery of statistical programming activities in support of clinical trials and regulatory submissions. This highly skilled role involves hands-on programming, advanced technical problem-solving, and leading cross-functional collaboration on complex statistical deliverables. The Principal Programmer will ensure high-quality programming outputs in compliance with industry standards and regulatory requirements, while also contributing to innovation in tools, processes, and infrastructure (e.g., Statistical Computing Environment, SCE).

This role acts as a critical technical interface between Biostatistics, Clinical Data Management (CDM), and other functions, driving consistency, efficiency, and quality across study and program-level deliverables.

Essential Duties and Responsibilities

Project Responsibilities:

• Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables.

• Lead or contribute to the development, validation, and documentation of SDTM, ADaM, and TFLs in support of clinical study reports, regulatory submissions, publications, and ad-hoc requests.

• Collaborate closely with Biostatisticians, Data Management, and Clinical teams to review SAPs, TLF shells, and data specifications to ensure alignment and clarity.

• Provide expert input and review of programming assumptions, table shells, and analysis specifications.

• Support the preparation of define.xml, e-submission-ready packages, and work with tools such as Pinnacle 21 for compliance checking.

• Ensure programming deliverables meet regulatory standards and are consistent with CDISC and company-defined specifications.

• Oversee CRO deliverables as needed, with a focus on technical quality and consistency rather than operational management.

Strategic and Initiative Responsibilities:

• Contribute to the development and optimization of programming standards, templates, and macros to improve team efficiency and quality.

• Collaborate with leadership on the design and enhancement of the Statistical Computing Environment (SCE), including folder structures, version control, and access management.

• Evaluate and implement innovative tools and programming technologies to streamline processes.

• Act as a subject matter expert (SME) during audits and inspections, with the ability to explain programming strategies and methodologies to regulatory agencies.

Qualifications and Preferred Skills
Education:

• Master’s degree in Statistics, Biostatistics, Computer Science, or a related field.

Experience:

• Minimum of 8 years of statistical programming experience in the pharmaceutical, biotech, or CRO environment.

• Expert-level SAS programming skills; proficiency in R is highly desirable.

• Deep understanding and hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements.